The collaboration will utilize Guardant’s liquid biopsy portfolio for the development of companion diagnostics for drug approvals.


Guardant Health Inc announced a multi-year strategic collaboration with Merck to develop companion diagnostics and support the commercialization of new cancer therapies using the Guardant Infinity Smart platform.

The precision oncology company says the partnership aims to accelerate clinical trial enrollment and regulatory approvals while improving patient access to molecular testing through Guardant’s diagnostic capabilities.

Under the agreement, Guardant and Merck will work together to identify and validate biomarkers for Merck’s oncology drug development programs. The collaboration leverages Guardant’s liquid biopsy technology and real-world data analytics to support therapy selection and patient stratification in clinical trials. Guardant and Merck aim to:

  • Use Guardant’s portfolio of liquid and tissue biopsy tests as clinical trial enrolling assays in Merck’s global clinical studies,
  • Evaluate opportunities to develop novel therapies using Guardant liquid biopsy tests as a companion diagnostic, and
  • Partner for global commercialization of drugs and companion diagnostics, including in the US, Asia-Pacific, UK, and EU markets.

“This strategic collaboration allows us to bring the power of the Infinity Smart platform to some of the most important oncology programs in development today,” says Helmy Eltoukhy, Guardant Health chairman and co-CEO, in a release. “As biomarkers become more central to therapy selection, our goal is to ensure that every trial has the molecular clarity needed to reach the right patients.”

The partnership represents Guardant’s continued expansion into companion diagnostic development, an area where pharmaceutical companies increasingly rely on molecular testing to identify patients most likely to benefit from targeted therapies.

Platform Integration for Drug Development

The Guardant Infinity Smart platform combines blood-based liquid biopsy testing with tissue-based genomic profiling and artificial intelligence analytics. The platform is designed to provide molecular insights across different stages of cancer care, from early detection through treatment selection for advanced disease.

For Merck, the collaboration provides access to Guardant’s established testing infrastructure and regulatory expertise in companion diagnostic development. Companion diagnostics are tests that identify patients suitable for specific targeted therapies, often required by regulatory agencies for drug approval.

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